while the QA Manager ensures all temperature excursions are properly documented and evaluated for product impact.

5. Procedure

5.1 Temperature Monitoring System

1. Continuous Monitoring:
   • All storage areas must be equipped with calibrated temperature monitoring devices that log data continuously.
   • Ensure alarms are configured to alert staff when temperatures exceed predefined thresholds.
   • Document temperature readings in the Temperature Monitoring Log (Annexure-1).
2. Manual Temperature Checks:
   • Warehouse personnel must perform manual temperature checks twice daily in all storage areas.
   • Record manual readings in the Manual Temperature Check Log (Annexure-2).

5.2 Identification of Temperature Excursions

1. Defining Excursions:
   • A temperature excursion is any deviation from the established storage conditions as per product specifications.
   • Examples include storage temperatures rising above 25°C for room-temperature materials or falling below 2°C for refrigerated items.
2. Immediate Actions:
   • Upon detection of an excursion, notify the Warehouse Supervisor and QA immediately.
   • Document the incident in the Temperature Excursion Report (Annexure-3).

5.3 Managing Temperature Excursions

1. Initial Response:
   • Verify the accuracy of the temperature reading using an independent thermometer.
   • Isolate affected materials to prevent further exposure.
   • Document immediate actions in the Initial Excursion Response Log (Annexure-4).
2. Corrective Actions:
   • The Maintenance team must investigate and resolve the root cause of the excursion (e.g., equipment malfunction, power failure).
   • Record corrective actions in the Temperature Excursion Corrective Action Log (Annexure-5).

5.4 Evaluation and Documentation

1. Impact Assessment:
   • QA will evaluate whether the temperature excursion has impacted the quality or stability of the raw materials.
   • Materials that are compromised must be quarantined and either re-tested or discarded based on QA’s recommendation.
   • Document assessments in the Temperature Excursion Impact Assessment Log (Annexure-6).
2. Final Documentation and Review:
   • Ensure all excursions, responses, and corrective actions are documented comprehensively.
   • Submit final reports for QA approval and file them in the Temperature Excursion Final Review Log (Annexure-7).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

7. Documents

1. Temperature Monitoring Log (Annexure-1)
2. Manual Temperature Check Log (Annexure-2)
3. Temperature Excursion Report (Annexure-3)
4. Initial Excursion Response Log (Annexure-4)
5. Temperature Excursion Corrective Action Log (Annexure-5)
6. Temperature Excursion Impact Assessment Log (Annexure-6)
7. Temperature Excursion Final Review Log (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
• ICH Q1A (R2) – Stability Testing of New Drug Substances and Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Temperature Monitoring Log

Date	Storage Area	Temperature Recorded	Monitoring Device ID	Recorded By
23/03/2025	Cold Storage Unit A	4°C	TS-1001	Ravi Kumar
23/03/2025	Warehouse Room Temperature Zone	22°C	TS-1002	Neha Verma

Annexure-2: Manual Temperature Check Log

Date	Time	Storage Area	Temperature Recorded	Checked By
23/03/2025	9:00 AM	Freezer Unit B	-18°C	Amit Joshi
23/03/2025	2:00 PM	Room Temperature Storage	24°C	Priya Singh

Annexure-3: Temperature Excursion Report

Date	Storage Area	Excursion Details	Duration	Reported By
23/03/2025	Cold Storage Unit A	Temperature rose to 8°C	2 hours	Ravi Kumar
23/03/2025	Room Temperature Zone	Temperature exceeded 25°C	3 hours	Neha Verma

Annexure-4: Initial Excursion Response Log

Date	Storage Area	Immediate Action Taken	Performed By
23/03/2025	Cold Storage Unit A	Moved materials to backup cold storage	Amit Joshi
23/03/2025	Room Temperature Zone	Checked HVAC system functionality	Priya Singh

Annexure-5: Temperature Excursion Corrective Action Log

Date	Storage Area	Corrective Action Taken	Performed By
23/03/2025	Cold Storage Unit A	Repaired malfunctioning compressor	Ravi Kumar
23/03/2025	Room Temperature Zone	Reset thermostat settings	Neha Verma

Annexure-6: Temperature Excursion Impact Assessment Log

Date	Material Name	Batch Number	Impact Assessment	Assessed By
23/03/2025	Citric Acid	CA-1234	No impact, material stable	Amit Joshi
23/03/2025	Sodium Hydroxide	NAOH-5678	Re-testing required	Priya Singh

Annexure-7: Temperature Excursion Final Review Log

Date	Excursion Summary	Final Review Status	Approved By
23/03/2025	Cold Storage Unit A excursion, no product impact	Closed	QA Head
23/03/2025	Room Temperature Zone excursion, re-testing required	Ongoing	QA Head

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
23/03/2025	2.0	Added corrective action protocols for excursions	To align with updated GMP and ICH guidelines	QA Head